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Clinical Trials/NCT02364414
NCT02364414CompletedNot Applicable

The Accuracy of Direct Digital Intra-oral Scanning Measurements Compared to Measurements on Study Models

Kettering General Hospital NHS Foundation Trust2 sites in 1 country22 target enrollmentStarted: December 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
2
Primary Endpoint
Measurement of tooth widths, arch lengths, overjet, overbite, crown heights and labio lingual widths

Study Overview

Brief Summary

The purpose of this study is to compare the accuracy of measurements derived from a commercially available direct intra-oral scanning system with those taken from plaster study models, and to compare cost implications of both systems.

The investigators will test the hypotheses:

  • There is no systematic difference between measurements taken from the Trios scanner and study models.
  • There is no difference in the cost of producing digital models.

Detailed Description

Plaster study models produced from moulds of the teeth are a standard component of orthodontic records. They are fundamental to diagnosis and treatment planning, evaluation of treatment progress and results as well as record keeping. (Santoro et al., 2003) Plaster models must be retained for a minimum of 11 years for a medico legal reasons. This leads to problems of storage in terms of space and cost, in addition to the risk of damage because of the brittle nature of the models. These problems therefore highlight the need for an alternative method for producing and storing study models. This study aims to compare the accuracy of measurements derived from a new commercially available direct intra-oral (inside of the mouth) scanning system (3Shape TRIOS (R)) with those taken from plaster study models, and to compare cost implications of both systems. We will use the results to conclude whether direct intra¬oral scanning can replace traditional plaster models produced from moulds of the teeth.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
11 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age range 11 years old to 18 years old.
  • Orthodontic patients with a range of malocclusions.
  • Dentition without abnormal morphology.
  • Adult/permanent dentition from the first molar to first molar in both arches.

Exclusion Criteria

  • Patients under 11 years old and over 18 years old.
  • Carious teeth or teeth with significantly altered anatomy.
  • Periodontal disease with significant gingival swelling.

Outcomes

Primary Outcomes

Measurement of tooth widths, arch lengths, overjet, overbite, crown heights and labio lingual widths

Time Frame: Within six weeks of initial intervention

All dental study models, and 3D scans will have all the above measurements carried out. There are 22 patients and each will have had study models made and these will be measured twice on two separate occasions, and all scans measured twice. The measurements will be compared and analysed to see if the 3D scans accurately represent the tooth sizes and measurements that have been carried out on the dental study models (gold standard).

Secondary Outcomes

  • Cost(within 6 months of initial intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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